Trial Outcomes & Findings for Ketamine Effect After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study (NCT NCT01997515)

Results Overview

Scores on QOR (quality of recovery) 40 questionnaire. The QoR-40 score, which ranges from 40 to 200, representing very poor (low scores) to outstanding quality of recovery (high scores), respectively.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

24 hours

Results posted on

2019-10-07

Participant Flow

Participant milestones

Participant milestones
Measure	Group K (Ketamine) Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).	Group P (Placebo) Group P (placebo) will receive the same amount of saline.
Overall Study STARTED	40	40
Overall Study COMPLETED	36	35
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group K (Ketamine) n=40 Participants Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).	Group P (Placebo) n=40 Participants Group P (placebo) will receive the same amount of saline.	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=80 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=40 Participants	40 Participants n=40 Participants	80 Participants n=80 Participants
Age, Categorical >=65 years	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=80 Participants
Sex: Female, Male Female	35 Participants n=40 Participants	27 Participants n=40 Participants	62 Participants n=80 Participants
Sex: Female, Male Male	5 Participants n=40 Participants	13 Participants n=40 Participants	18 Participants n=80 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 24 hours

Scores on QOR (quality of recovery) 40 questionnaire. The QoR-40 score, which ranges from 40 to 200, representing very poor (low scores) to outstanding quality of recovery (high scores), respectively.

Outcome measures

Outcome measures
Measure	Group K (Ketamine) n=36 Participants Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).	Group P (Placebo) n=35 Participants Group P (placebo) will receive the same amount of saline.
Quality of Recovery 40	170 score on a scale Interval 158.0 to 177.0	179 score on a scale Interval 166.0 to 187.0

SECONDARY outcome

Timeframe: 24 hours

Total number of opioids (morphine equivalents) consumed 24 hours after surgery

Outcome measures

Outcome measures
Measure	Group K (Ketamine) n=36 Participants Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).	Group P (Placebo) n=35 Participants Group P (placebo) will receive the same amount of saline.
Postoperative Opioid Consumption	4.45 Morphine Equivalents Interval 3.0 to 7.83	6.3 Morphine Equivalents Interval 3.6 to 10.1

SECONDARY outcome

Timeframe: 24 hours

Participants pain scores will be recorded at 24 hours after surgery. Pain scores range from 0 (no pain) to 10 (worst pain imaginable).

Outcome measures

Outcome measures
Measure	Group K (Ketamine) n=36 Participants Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).	Group P (Placebo) n=35 Participants Group P (placebo) will receive the same amount of saline.
Postoperative Pain Scores	4 score on a scale Interval 2.25 to 5.75	4 score on a scale Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: Up to 2 weeks

The subjects length of hospital stay will be recorded. Length of stay is defined as day of surgery to date of discharge from the hospital which may be up to 2 weeks..

Outcome measures

Outcome measures
Measure	Group K (Ketamine) n=36 Participants Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).	Group P (Placebo) n=35 Participants Group P (placebo) will receive the same amount of saline.
Length of Hospital Stay	2.00 days Interval 2.0 to 2.75	2.00 days Interval 2.0 to 2.0

Adverse Events

Group K (Ketamine)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group P (Placebo)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Research

Rhode Island Hospital

Phone: 401-444-4933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place